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Efficacy and safety of liraglutide versus sitagliptin, both in combination with metformin, in Chinese patients with type 2 diabetes: a 26‐week, open‐label, randomized, active comparator clinical trial
Author(s) -
Zang L.,
Liu Y.,
Geng J.,
Luo Y.,
Bian F.,
Lv X.,
Yang J.,
Liu J.,
Peng Y.,
Li Y.,
Sun Y.,
BoschTraberg H.,
Mu Y.
Publication year - 2016
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12674
Subject(s) - liraglutide , sitagliptin , medicine , metformin , type 2 diabetes , clinical endpoint , gastroenterology , dipeptidyl peptidase 4 inhibitor , diabetes mellitus , sitagliptin phosphate , endocrinology , nausea , type 2 diabetes mellitus , randomized controlled trial
Aims To compare the efficacy and safety of liraglutide versus sitagliptin as add‐on to metformin after 26 weeks of treatment in Chinese patients with type 2 diabetes mellitus ( T2DM ). Methods This 26‐week open‐label, active comparator trial ( NCT02008682 ) randomized patients (aged 18–80 years) with T2DM inadequately controlled with metformin [glycated haemoglobin ( HbA1c ) 7.0–10.0% (53–86 mmol/mol)] 1 : 1 to once‐daily subcutaneously administered liraglutide 1.8 mg (n = 184) or once‐daily oral sitagliptin 100 mg (n = 184), both as add‐on to metformin. The primary endpoint was change in HbA1c from baseline to week 26. Results Liraglutide was superior to sitagliptin in reducing HbA1c from baseline [8.1% (65 mmol/mol)] to 26 weeks, as evidenced by estimated mean HbA1c change of −1.65% (−18.07 mmol/mol) versus −0.98% (−10.72 mmol/mol), respectively [estimated treatment difference for liraglutide vs sitagliptin of −0.67% (95% CI −0.86, −0.48) or −7.35 mmol/mol (95% CI −9.43; −5.26); p < 0.0001]. More patients receiving liraglutide (76.5%) than sitagliptin (52.6%) achieved the HbA1c target of <7.0% (53 mmol/mol) at week 26 [odds ratio 3.65 (95% CI 2.18, 6.12); p < 0.0001]. Reductions in fasting plasma glucose, 7‐point self‐measured plasma glucose and body weight were greater with liraglutide than with sitagliptin (p < 0.0001 for all). More patients experienced nausea (14.8% vs 0.5%), diarrhoea (8.2% vs 2.2%) and decreased appetite (10.9% vs 0.5%) with liraglutide than sitagliptin. Two hypoglycaemic episodes were confirmed for liraglutide and one for sitagliptin; none were severe or nocturnal. Conclusions Liraglutide provided better glycaemic control and greater body weight reduction than sitagliptin when administered as add‐on to metformin. More patients had nausea, diarrhoea and decreased appetite with liraglutide versus sitagliptin.